Purevive Health Sciences, LLC

CLOSEOUT LETTER Purevive Health Sciences, LLC MARCS-CMS 489944 — June 14, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Purevive Health Sciences, LLC United States Issuing Office: United States Office of Human and Animal Foods Division West 5 Los Angeles District Office 19701 Fairchild, Irvine, CA 92612 Telephone: 949-608-4496 UNITED PARCEL SERVICE SIGNATURE REQUIRED June 14, 2018 Carmen P. Bickell, Owner Pure Vive Health Sciences, LLC formerly Vitalife, Inc. dba Tabak's Health Products 11258 Monarch St., Ste. L Garden Grove, CA 92841 RE: WL #33-16 Close-Out Letter Dear Ms. Bickell: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #33-16, dated June 20, 2016. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Sergio Chavez Director Compliance Branch Food and Drug Administration HAF Division West 5 Content current as of: 06/25/2018